MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. DREAMSTATION CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DSX500S11F

Device Problems Nonstandard Device (1420); Contamination /Decontamination Problem (2895)

Patient Problem Insufficient Information (4580)

Event Date 03/01/2023

Event Type  malfunction  

Event Description

I use a philips dreamstation c-pap, which was affected by the insulation recall.I received my replacement device from them, only to find it was visibly dirty.It is supposed to be "refurbished" but instead i'm getting someone else's trash machine.I find this to be unacceptable, especially since i am required to send my machine back which is in excellent condition.Whenever i have tried calling philips they transfer me around from one agent to another.Of note, the filter that was in the machine was visibly dirty as well but i have discarded it already.Continuous positive air pressure therapy.Reference report mw5115996.

• Brand Name: DREAMSTATION CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 16627046
• MDR Text Key: 312168751
• Report Number: MW5115995
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DSX500S11F
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ROPINEROLE
• Patient Outcome(s): Other
• Patient Age: 27 YR
• Patient Sex: Male
• Patient Weight: 120 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White